The European Medicines Agency is considering making a rapid recommendation on MSD’s molnupiravir in order to speed access to the potential ‘game changer’ COVID-19 pill.
The European Medicines Agency is considering making a rapid recommendation on MSD’s molnupiravir in order to speed access to the potential ‘game changer’ COVID-19 pill.
The oral antiviral has been shown to cut hospitalization and deaths by 50% in at-risk patients in the early stages...
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
